FDA Device Recall Z-0094-2024

EITAN MEDICAL LTD · Netanya, N/A

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)

Lot / serial / GTIN: Software Revision: 16.10.1 or 16.10.2 REF/UDI-DI: 15031-000-0028/7290109150109, 15032-000-0027/7290109150147, 15038-000-0001/7290109150161

Quantity: 1383

Reason for recall

Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.

Recall record

Recall number: Z-0094-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US nationwide distribution.
Recall initiated: 2023-09-11
Classified by FDA Center: 2023-10-19
FDA published: 2023-10-25
Recalling firm: EITAN MEDICAL LTD
Firm location: Netanya, N/A, Israel

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All device recalls